NCT03789591 (HOPS) is a Phase 3 clinical trial of Hydroxyurea in Sickle Cell Disease, sponsored by Lifespan.

Who is sponsoring NCT03789591?

NCT03789591 is sponsored by Lifespan.

What drugs are being tested in NCT03789591?

Interventions in NCT03789591: Hydroxyurea.

What condition does NCT03789591 study?

NCT03789591 studies Sickle Cell Disease, Sickle Cell Anemia.

Is NCT03789591 still recruiting?

NCT03789591 is currently completed. Last updated 18 June 2025.

Last reviewed 2025-06-18 · How we verify

NCT03789591: HOPS

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Hydroxyurea Optimization Through Precision Study

Completed Phase 3 Last updated 18 June 2025

What this trial tests

Phase 3 trial testing Hydroxyurea in Sickle Cell Disease in 104 participants. Completed in 19 March 2025.

Timeline

17 January 2019

Primary endpoint
19 March 2025

19 March 2025

Quick facts

Lead sponsor	Lifespan
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	104
Start date	17 January 2019
Primary completion	19 March 2025
Estimated completion	19 March 2025
Sites	13 locations across United States

Drugs / interventions tested

Hydroxyurea — full drug profile →

Conditions studied

Sickle Cell Disease — all drugs for Sickle Cell Disease →
Sickle Cell Anemia — all drugs for Sickle Cell Anemia →

Sponsor

Lifespan — full company profile →

Who can join

Adults 6 Months to 21, any sex, with Sickle Cell Disease or Sickle Cell Anemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Hydroxyurea Optimization through Precision Study (HOPS) is a prospective, multi-center, randomized trial that will directly compare a novel, individualized dosing strategy of hydroxyurea to standard weight-based dosing for children with SCA. The primary objective of the study is to evaluate whether a pharmacokinetics-based starting hydroxyurea dose thieves superior fetal hemoglobin response to to standard weight-based initial dosing. Patients will be recruited from the pediatric sickle cell clinic at Cincinnati Children's Hospital Medical Center and from additional pediatric sickle cell centers within the United States.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Robust clinical and laboratory response to hydroxyurea using pharmacokinetically guided dosing for young children with sickle cell anemia.
McGann PT, Niss O, Dong M, Marahatta A, et al · · 2019 · cited 61× · PMID 31106898 · DOI 10.1002/ajh.25510
Emerging disease-modifying therapies for sickle cell disease.
Carden MA, Little J. · · 2019 · cited 60× · PMID 31413089 · DOI 10.3324/haematol.2018.207357
A comprehensive review of hydroxyurea for β-haemoglobinopathies: the role revisited during COVID-19 pandemic.
Yasara N, Premawardhena A, Mettananda S. · · 2021 · cited 23× · PMID 33648529 · DOI 10.1186/s13023-021-01757-w
Changing the Clinical Paradigm of Hydroxyurea Treatment for Sickle Cell Anemia Through Precision Medicine.
Dong M, McGann PT. · · 2021 · cited 18× · PMID 32869281 · DOI 10.1002/cpt.2028
Hydroxyurea Optimization through Precision Study (HOPS): study protocol for a randomized, multicenter trial in children with sickle cell anemia.
Meier ER, Creary SE, Heeney MM, Dong M, et al · · 2020 · cited 14× · PMID 33246482 · DOI 10.1186/s13063-020-04912-z
Using disease-modifying therapies in sickle cell disease.
Rai P, Ataga KI. · · 2023 · cited 4× · PMID 38066905 · DOI 10.1182/hematology.2023000485
Hydroxyurea pharmacokinetics in children with sickle cell anemia across different global populations.
Power-Hays A, McElhinney KE, Williams TN, Mochamah G, et al · · 2026 · cited 3× · PMID 41026975 · DOI 10.1182/bloodadvances.2025017254
The Coming of Age of Model-Informed Precision Therapeutics for Children.
Vinks AA. · · 2025 · PMID 41415930 · DOI 10.5863/jppt-25-01219

Verify or expand the search:

Other trials of Hydroxyurea

Trials testing the same drug.

NCT06930352 — Ziftomenib for the Treatment of Patients With NPM1 Mutated or KMT2A Rearranged Acute Myeloid Leukemia Not Eligible for S · Phase 2 · not yet recruiting
NCT06871410 — Genetically Engineered Cells (CD83 CAR T Cells) for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia · Phase 1 · recruiting
NCT06526117 — Stroke Prevention in Nigeria 2 Trial · Phase 4 · recruiting
NCT06456346 — Bomedemstat vs Hydroxyurea for Essential Thrombocythemia (MK-3543-007) · Phase 3 · recruiting
NCT05285917 — Promoting Utilization and Safety of Hydroxyurea Using Precision in Africa · Phase 3 · recruiting

Other recruiting trials for Sickle Cell Disease

Currently open trials in the same condition.

NCT07369024 — Sub-dissociative Dose Ketamine in Treatment of Vaso-occlusive Pain Event in Children and Young Adults · Phase 2 · recruiting
NCT06016634 — Alendronate for Osteonecrosis in Adults With Sickle Cell Disease · Phase 2 · recruiting
NCT06260891 — Zinc Supplementation in Sickle Cell Disease: A Precursor to the Think Zinc for Bones Trial · Phase 2 · recruiting
NCT07222475 — Writing Relaxing Beats in Adolescents Who Have Sickle Cell Disease · NA · recruiting
NCT07224360 — Safety of Anumigilimab (CSL324) in Adults With Sickle Cell Disease (SCD) · Phase 2 · recruiting

Other Lifespan trials

Trials by the same sponsor.

NCT06805799 — Stress Reactivity and Mother-Infant Cardiovascular Disease Risk · NA · not yet recruiting
NCT05512143 — TMS for PTSD and Blood Pressure · NA · active not recruiting
NCT05646446 — Integrated Alcohol and Sexual Assault Prevention for Bisexual Women · NA · withdrawn
NCT06354465 — Injectable Extended-Release Buprenorphine (XR-B) in a Correctional Setting: Qualitative Interviews · recruiting
NCT05599620 — Reducing Alcohol Use and Sexual Dysfunction in Survivors of Sexual Trauma · NA · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03789591 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Lifespan
Last refreshed: 18 June 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03789591.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing